German HTA slams cagey Chiesi disclosure on Glybera bad news
This article was originally published in Scrip
The G-BA, the body in charge of Germany's AMNOG health technology appraisals, is "bewildered" that it learned about a potentially damming EMA risk benefit report on Chiesi/uniQure's gene therapy Glybera from the US Security and Exchange Commission and not the company responsible for the drug. The G-BA was due to publish a resolution declaring that the orphan drug has additional therapeutic value on 16 April, but has instead decided to suspend the process.
You may also be interested in...
An agreement between Vertex and NHS England secures rapid access to Kaftrio, the company’s triple therapy for cystic fibrosis, including for patients with rare mutations not covered by the soon-to-be-granted European marketing authorization. The final price will depend on an assessment by health technology appraisal body NICE.
Public health advocates say that commercial concerns must take a back seat to health interests if COVID-19 technologies are to be made available to those who need them. But industry says that relaxing IP protections is not the solution and that many companies have already invested significant amounts of money in potential new treatments and vaccines.
Recommending new medicines for approval and allowing sponsors of others extra time to answer outstanding questions are among the many tasks on the agenda of the March meeting of European Medicines Agency's key scientific committee, the CHMP. The meeting has been taking place, remotely, this week.